Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Empagliflozin (BI 10773); Drug: Probenecid; Drug: Empagliflozin; Drug: Rifampicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634100

1245.83

2012-000971-17 (EudraCT Number)

Details and patient eligibility

About

The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.

Enrollment: 18 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. healthy male and female subjects

Exclusion criteria

1. any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

A (Reference)

Experimental group

Description:

Empagliflozin (BI 10773), Film-coated tablet, single dose

Treatment:

Drug: Probenecid

Drug: Empagliflozin

Drug: Rifampicin

Drug: Rifampicin

Drug: Probenecid

Drug: Empagliflozin

B (Test 1)

Experimental group

Description:

Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose

Treatment:

Drug: Empagliflozin

Drug: Rifampicin

Drug: Rifampicin

Drug: Empagliflozin

C (Test 2)

Experimental group

Description:

Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily

Treatment:

Drug: Probenecid

Drug: Probenecid

Drug: Empagliflozin (BI 10773)